1 Sui-Lee Wee, China Uses DNA to Track Its People, With the Help of American Expertise, N.Y. Times (Feb. 21, 2019), https://www.nytimes.com/2019/02/21/business/china-xinjiang-uighur-dna-thermo-fisher.html [https://perma.cc/BD48-PM4B].

2 Id.

3 For an understanding of the term biobank, see generally Alice Park, 10 Ideas Changing the World Right Now: Biobanks, Time (Mar. 12, 2009), http://content.time.com/time/specials/packages/article/0,28804,1884779_1884782_1884766,00.html [https://perma.cc/9743-FNT3] (defining biobanks as “a safe house for tissue samples, tumor cells, DNA and…even blood…that would be used for research into new treatments for diseases”).

4 Kaye, Jane, The Tension Between Data Sharing and the Protection of Privacy in Genomics Research, 13 Ann. Rev. Genomics & Hum. Genetics, 415, 416 (2012)Google ScholarPubMed.

5 McGuire, Amy L. & Beskow, Laura M., Informed Consent in Genomics and Genetic Research, 11 Ann. Rev. Genomics & Hum. Genetics 361, 362 (2010)Google ScholarPubMed.

6 Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191, 110 Stat. 1936 (1996).

7 See discussion infra Part III.

8 See discussion infra Section I.A.

9 See McGuire & Beskow, supra note 5.

10 The Human Genome Project cost an estimated $2.7 billion but based on recent data from the National Human Genome Research Institute, the cost to generate a high-quality whole human genome sequence fell below $1,500 by late 2015. The Cost of Sequencing a Human Genome, Nat'l Human Genome Research Inst. (Oct. 30, 2019), https://www.genome.gov/27565109/the-cost-of-sequencing-a-human-genome/ [https://perma.cc/5KN9-6TFC].

11 “In a six or seven month period, it's recruited way more than a thousand consumers, almost ten times as many as our original experiment.” Interview by Institute for Systems Biology with Lee Hood, Co-Founder, Institute for Systems Biology (Oct. 31, 2016), https://systemsbiology.org/about/overview/ [https://perma.cc/QWS3-SMEV] (discussing personalized genomic medicine project at 09:30).

12 See 45 C.F.R. § 164.514(b)(2) (2020).

13 Gymrek, Melissa et al., Identifying Personal Genomes by Surname Inference, 339 Sci. 321, 321 (2013)CrossRefGoogle ScholarPubMed; see also Couzin, Jennifer, Whole-Genome Data Not Anonymous, Challenging Assumptions, 321 Sci. 1278, 1278 (2008)CrossRefGoogle Scholar.

14 Genomic medicine is defined by the National Human Genome Research Institute as, “an emerging medical discipline that involves using genomic information about an individual as part of their clinical care and the health outcomes and policy implications of that clinical use.” Genomics and Medicine, Nat'l Human Genome Research Inst. (Apr. 30, 2019), https://www.genome.gov/health/Genomics-and-Medicine [https://perma.cc/8EC9-24V4].

15 Genes, Genome News Network (Jan. 15, 2003), http://www.genomenewsnetwork.org/resources/whats_a_genome/Chp1_3_1.shtml [https://perma.cc/8ZMY-6W5Y].

16 Id.

17 Human Genome Project FAQ, Nat'l Human Genome Research Inst. (Feb. 24, 2020), https://www.genome.gov/11006943/ [https://perma.cc/S565-9CWE].

18 “To illustrate the size of the genome, if we printed the single letter abbreviation of each base (A, C, T, G) of the entire genome sequence in a standard print size, we would end up with a stack of paper about as tall as the Washington Monument.” What is the Human Genome Project?, Nat'l Human Genome Research Inst. (Oct. 28, 2018), https://www.genome.gov/human-genome-project/What [https://perma.cc/RX77-KW9S] [hereinafter What is the Human Genome Project?].

19 “One gene can affect several traits; one trait may be affected by several genes. And most traits are also influenced by an individual's environment, which includes hundreds of internal and external variables.” Genome News Network, supra note 15.

20 Organization, Nat'l Human Genome Research Inst. (Mar. 2, 2019), https://www.genome.gov/about-nhgri/Organization [https://perma.cc/U5NK-AFCY].

21 International Consortium Completes Human Genome Project, Nat'l Human Genome Research Inst. (May 8, 2012), https://www.genome.gov/11006929/2003-release-international-consortium-completes-hgp [https://perma.cc/5QYV-ZEGA]. The Human Genome Project was a publicly-funded, international project conducted by the International Genome Sequencing Consortium. Id.

22 Sinsheimer, Robert, The Santa Cruz Workshop – May 1985, 5 Genomics 954, 954-56 (1989)CrossRefGoogle Scholar.

23 What Was the Human Genome Project and Why Has It Been Important?, Nat'l Inst. Health (Mar. 3, 2020), https://ghr.nlm.nih.gov/primer/hgp/description [https://perma.cc/7G85-NT8M].

24 See infra Part III.

25 Xinghua Shi & Xintao Wu, An Overview of Human Genetic Privacy, 1387 Annals N.Y. Acad. Sci. 61 (2017) (explaining the limitations of HIPAA and the need for “international legal harmonization in relation to genetic data protection”).

26 See Kaye, supra note 4 (citations omitted).

27 The principle of open access to genetic data for the HGP is sometimes directly attributed to the Welcome Trust Sanger Institute. Powledge, Tabitha M., Human Genome Project Completed, 4 Genome Biology 1, 1 (2003)CrossRefGoogle Scholar, https://genomebiology.biomedcentral.com/articles/10.1186/gb-spotlight-20030415-01 [https://perma.cc/EZR8-G7UB].

28 See, e.g., Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 576-77 (2013) (holding that although isolation of naturally occurring DNA cannot be patented, composite DNA can be patented).

29 See Kaye, supra note 4, at 3. “Achieving research goals and priorities at an international level would not have occurred at the same scale and speed without the advances in bioinformatics and computing technology, which in turn have led to changes in scientific practice and the way that research is carried out.” Id. (citations omitted).

30 What is the Human Genome Project?, supra note 18.

31 See Schwarze, Katharina et al., Are Whole-exome and Whole-genome Sequencing Approaches Cost-effective? A Systematic Review of the Literature, 20 Genetics Med. 1122, 1122 (2018)CrossRefGoogle ScholarPubMed (citing Sally C. Davies, Annual Report of the Chief Medical Officer 2016, Generation Genome, Dep't Health: London (2017)).

32 See The Cost of Sequencing a Human Genome, Nat'l Human Genome Research Inst., supra note 10.

33 See id. (noting that although the HGP was projected to cost $3 billion, it was completed two years ahead of schedule and under-budget).

34 See id. (“The cost to generate a whole-exome sequence was generally below $1,000. Commercial prices for whole-genome and whole-exome sequences have often (but not always) been slightly below these numbers.”).

35 North American Precision Medicine Market - Outlook to 2023: Technological Advancements, Bus. Wire (Nov. 16, 2018, 12:17 PM), https://www.businesswire.com/news/home/20181116005405/en/North-American-Precision-Medicine-Market—Outlook [https://perma.cc/P2J6-JTN6].

36 See Scientific Wellness, Inst. Sys. Biology, https://isbscience.org/research/scientificwellness/ [https://perma.cc/JZN2-T34L] (last visited Mar. 10, 2020) (explaining that because“[t]he ability to prevent disease will in turn make it possible to personalize medicine…[t]he result will be personalized predictions of disease and personalized treatment to prevent disease”).

37 Robert Gebelhoff, Sequencing the Genome Creates So Much Data We Don't Know What to Do With It, Wash. Post (July 7, 2015, 3:06 PM), https://www.washingtonpost.com/news/speaking-of-science/wp/2015/07/07/sequencing-the-genome-creates-so-much-data-we-dont-know-what-to-do-with-it [https://perma.cc/24P3-4DJX].

38 Jessica Davis, Why Legal Challenges Could Slow Down Precision Medicine, Healthcare IT News (June 13, 2017, 2:36 PM), https://www.healthcareitnews.com/news/why-legal-challenges-could-slowdown-precision-medicine [https://perma.cc/E56W-5P26] (“To [an] attorney for Mayo Clinic Department of Laboratory Medicine and Pathology, there are four major legal challenges to precision medicine: Navigating research and privacy protections on gathered data; providing affordable testing for patients without breaking fraud and abuse laws; responsibly using results as the data evolves; and discrimination.”).

39 “According to the Precision Medicine Initiative, precision medicine is ‘an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.’” What is Precision Medicine?, Nat'l Inst. Health, https://ghr.nlm.nih.gov/primer/precisionmedicine/definition [https://perma.cc/M538-W56A] (last visited Mar. 10, 2020) (quoting Garrido, P. et al., Proposal for the Creation of a National Strategy for Precision Medicine in Cancer: A Position Statement of SEOM, SEAP, and SEFH, 20 Clinical & Translational Oncology 443, 443 (2019)CrossRefGoogle Scholar).

40 Nic's Story, Ctr. for BioMolecular Modeling, http://cbm.msoe.edu/scienceOlympiad/module2012/volkerStory.html [https://perma.cc/MV25-2QWC] (last visited Apr. 16, 2020).

41 See Mark Johnson & Kathleen Gallagher, One in a Billion: A Boy's Life, a Medical Mystery. Part 1: A Baffling Illness, Milwaukee J. Sentinel (Dec. 18, 2010), http://archive.jsonline.com/features/health/111641209.html [https://perma.cc/EC47-8QGM].

42 The operations included numerous bowel resections and a colectomy. See id.

43 See Mark Johnson & Kathleen Gallagher, One in a Billion: A Boy's Life, a Medical Mystery. Part 2: Sifting Through the DNA Haystack, Milwaukee J. Sentinel (Dec. 21, 2010), http://archive.jsonline.com/features/health/112248249.html [https://perma.cc/898C-X2TY].

44 See id.

45 Matthew Herper, The First Child Saved by DNA Sequencing, Forbes (Jan. 5, 2011, 4:57 PM), https://www.forbes.com/sites/matthewherper/2011/01/05/the-first-child-saved-by-dna-sequencing/#7cf5115737c0 [https://perma.cc/25VY-3GXS].

46 Boycott, Kym M. et al., International Cooperation to Enable the Diagnosis of All Rare Genetic Diseases, 100 Am. J. Hum. Genetics 695, 696 (2017)CrossRefGoogle Scholar.

47 Id. at 695 (“Provision of a molecularly confirmed diagnosis in a timely manner for children and adults with rare genetic diseases shortens their ‘diagnostic odyssey,’ improves disease management, and fosters genetic counseling with respect to recurrence risks while assuring reproductive choices.”).

48 See Vassy, Jason L. et al., How Primary Care Providers Talk to Patients About Genome Sequencing Results: Risk, Rationale, and Recommendation, 33 J. Gen. Internal Med. 877, 877-78 (2018)CrossRefGoogle ScholarPubMed.

49 In 2019, and in the United States specifically, this type of clinical treatment is most commonly offered in research and teaching practices, such as Stanford Primary Care. See, e.g., Primary Care, Stan. Med., http://med.stanford.edu/pcph/patient-care/primary-care.html [https://perma.cc/N55T-WCRJ] (last visited Mar. 10, 2020).

50 Heather Mack, How Stanford Health Care is Bringing Precision Medicine into Preventive Primary Care, MobiHealthNews (June 6, 2017), https://www.mobihealthnews.com/content/how-stanford-health-care-bringing-precision-medicine-preventive-primary-care [https://perma.cc/9WUN-V7JT].

51 See Moscatelli, Marco et al., An Infrastructure for Precision Medicine through Analysis of Big Data, 19 BMC Bioinfomatics 51, 52 (2018)Google ScholarPubMed (“The big data, together with the development of novel data mining algorithms, provide the bases for novel insights into diseases that can be translated into personalized treatments.”).

52 Biobanks are defined as “a storage place for biological samples (such as human tissue, blood, or DNA) that may be used especially for future medical research.” Biobank, Merriam-Webster (2019).

53 See Moscatelli et al., supra note 51.

54 A direct-to-consumer DNA testing company recently made a $300 million-dollar deal with GlaxoSmithKline. Sarah Zhang, Big Pharma Would Like Your DNA, Atlantic (July 28, 2018), https://www.theatlantic.com/science/archive/2018/07/big-pharma-dna/566240/ [https://perma.cc/8WU5-M65D].

55 Kinkorová, Judita, Biobanks in the Era of Personalized Medicine: Objectives, Challenges, and Innovation, 7 EPMA J. 1, 1 (2016)Google Scholar (“Biobanks are an essential tool for new drug discoveries and drug development. Biobanks play an important role in the whole process of patient prevention and prediction, follow-up, and therapy monitoring and optimalization.”).

56 Id.

57 See Moscatelli et al., supra note 51.

58 Id.

59 Goodman, Deborah et al., De-identified Genomic Data Sharing: The Research Participant Perspective, 8 J. Community Genetics 173, 173-74 (2017)CrossRefGoogle ScholarPubMed.

60 Id. at 177.

61 Dankar, Fida K. et al., The Development of Large-scale De-identified Biomedical Databases in the Age of Genomics – Principles and Challenges, 12 Human Genomics 1, 7 (2018)CrossRefGoogle ScholarPubMed.

62 See id. at 11-12.

63 Greenly, Henry T., The Uneasy Ethical and Legal Underpinnings of Large-Scale Genomic Biobanks, 8 Ann. Rev. Genomics & Hum. Genetics 343, 364 (2007)Google Scholar.

64 See Vassy et al., supra note 48.

65 See id. at 877, 883.

66 Scientific Wellness, Inst. Sys. Biology, supra note 36. The Institute for Systems Biology, one of the U.S. facilities that participated in the HGP, has branded its precision medicine initiative as “P4 Medicine.” Id.

67 See id.

68 Fisher, Celia B. & Layman, Deborah M., Genomics, Big Data, and Broad Consent: A New Ethics Frontier for Prevention Science, 19 Prevention Sci. 871, 872 (2018)CrossRefGoogle ScholarPubMed.

69 Chris Orchard, Genomic Medicine in the Real World: ‘Hope’ and ‘Hype’, Harvard Sch. Pub. Health (June 1, 2015), https://www.hsph.harvard.edu/ecpe/genomic-medicine-in-the-real-world-hope-andhype/ [https://perma.cc/GP24-KUZX].

70 Id. (“Pharmacogenomics, explained Jimenez-Sanchez, involves assessing an individual's genome and targeting specific drug treatments to fit that individual. Due to genetic variations, individuals can respond differently to common drugs, and specialized drugs can often be used with people – sometimes only a handful of them – who have rare disorders caused by genetic mutations.”).

71 See Souza, Yvonne G. De & Greenspan, John S., Biobanking Past, Present and Future: Responsibilities and Benefits, 27 AIDS 303, 303-04 (2013)CrossRefGoogle ScholarPubMed; Orchard, supra note 69.

72 President Barack Obama, Remarks in the State of the Union Address (Feb. 12, 2013), https://obamawhitehouse.archives.gov/the-press-office/2013/02/12/remarks-president-state-union-address [https://perma.cc/4T8F-GML6].

73 Battelle Tech. P'ship Practice, The Impact of Genomics on the U.S. Economy 3 (2013), https://web.ornl.gov/sci/techresources/Human_Genome/publicat/2013BattelleReportImpact-of-Genomics-on-the-US-Economy.pdf [https://perma.cc/W7N9-MC3R] [hereinafter Battelle].

74 Id.

75 Orchard, supra note 69.

76 Battelle, supra note 73.

77 The Precision Medicine Initiative, White House, https://obamawhitehouse.archives.gov/precision-medicine [https://perma.cc/ZM3G-ZYJ9] (last visited Mar. 11, 2020). The Precision Medicine Initiative also developed principles for privacy protection and data security policies. See discussion infra Part VI.

78 See Kaye, supra note 4, at 5.

79 Warren, Samuel D. & Brandeis, Louis D., The Right to Privacy, 4 Harv. L. Rev. 193, 193 (1890)CrossRefGoogle Scholar.

80 Chlapowski, Francis S., Note, The Constitutional Protection of Informational Privacy, 71 B.U. L. Rev. 133, 135 (1991)Google Scholar.

81 “Physical privacy is a restriction on the ability of others to experience a person through one or more of the five senses; informational privacy is a restriction on facts about the person that are unknown or unknowable; and decisional privacy is the exclusion of others from decisions, such as health care decisions or marital decisions, made by the person and his group of intimates.” Caroline Whitbeck, Part 4. Privacy, Confidentiality, Intellectual Property and the Law, in 2.95J Real World Ethics Course, http://web.mit.edu/course/2/2.95j/readings/finepoints.html#ref5 [https://perma.cc/PJ69-XVEA] (last visited Mar. 11, 2020).

82 Leigh, Lawrence J., Informational Privacy: Constitutional Challenges to the Collection and Dissemination of Personal Information by Government Agencies, 3 Hastings Const. L.Q. 229, 236 (1976)Google Scholar (quoting A. Westin, Privacy And Freedom (1967)).

83 Nate Lord, Top 10 Biggest Government Data Breaches of All Time in the U.S., Digital Guardian: DataInsider (Sept. 12, 2018), https://digitalguardian.com/blog/top-10-biggest-us-government-data-breaches-all-time [https://perma.cc/N7N9-CPJU].

84 See Dankar et al., supra note 61, at 7.

85 See Kaye, supra note 4, at 416.

86 Whalen v. Roe, 429 U.S. 589, 605 (1977).

87 “However, the accessibility of relatives to investigators in database queries raises privacy and legal policy concerns, as considerations guiding appropriate inclusion of DNA profiles in databases and subsequent use of those profiles generally focus on the contributors of the profiles rather than on close relatives who are rendered accessible to investigators.” Kim, Jaehee et al., Statistical Detection of Relatives Typed with Disjoint Forensic and Biomedical Loci, 175 Cell 848, 848 (2018)CrossRefGoogle ScholarPubMed.

88 Schilit, Samantha L.P. & Nitenson, Arielle Schilit, My Identical Twin Sequenced Our Genome, 26 J. Genetic Counseling 276, 276 (2016)CrossRefGoogle ScholarPubMed.

89 Id.

90 Id. at 276-77.

91 Id. at 277.

92 Id.

93 Id.

94 See Stuart Leavenworth, Iceland Faces DNA Dilemma: Whether to Notify People Carrying Cancer Genes, Seattle Times (June 15, 2018, 8:13 AM), https://www.seattletimes.com/nation-world/iceland-faces-a-dna-dilemma-whether-to-notify-people-carrying-cancer-genes/.

95 Guðmundsdóttir v. Iceland, No. 151/2003 (Nov. 27, 2003) (Ice.); Meyer, Michelle, Icelandic Supreme Court Holds that Inclusion of an Individual's Genetic Information in a National Database Infringes on the Privacy Interests of His Child, 118 Harv. L. Rev. 810, 810 (2004)Google Scholar (citations omitted).

96 Meyer, supra note 95, at 810-11.

97 See Guðmundsdóttir, No. 151/2003; Meyer, supra note 95, at 810-11.

98 See Guðmundsdóttir, No. 151/2003; Meyer, supra note 95, at 810-11.

99 For a more detailed explanation of the Icelandic Supreme Court's decision, see Meyer, supra note 95, at 812.

100 Leavenworth, supra note 94.

101 Id. Because of various cultural and legal challenges, deCODE has backed away from its initial goal of creating the national Health Sector Database, and now participates in more conventional methodology, collecting and analyzing samples to study specific diseases. See Greenly, supra note 63, at 348.

102 Whitbeck, supra note 81.

103 See Tracy Samilton, Parents Sue Over State's Newborn Blood Testing for Genetic Diseases, Nat'l Pub. Radio: Mich. Radio (Apr. 12, 2018), https://www.michiganradio.org/post/parents-sue-overstates-newborn-blood-testing-genetic-diseases [https://perma.cc/NG9E-CUKH].

104 Id. (“Unless the parents opt out, the blood is kept indefinitely and sold to a private blood bank for research: the Michigan NeoNatal Blood Bank, a subsidiary of Wayne State University.”).

105 McGuire, Amy L., Identifiability of DNA: The Need for Consistent Federal Policy, 8 Am. J. Bioethics 75, 75-76 (2008)CrossRefGoogle ScholarPubMed.

106 See discussion infra Part III.

107 McGuire & Beskow, supra note 5, at 361.

108 See id. at 362.

109 See id. at 362-63.

110 Id. at 363.

111 Timothy Caulfield & Blake Murdoch, Genes, Cells, and Biobanks: Yes, There's Still a Consent Problem, PLOS Biology, July 25, 2017, at 2, https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.2002654 [https://perma.cc/C362-VGEY].

112 Greenly, supra note 63, at 357.

113 See id. (“The Nuremberg Code, Declaration of Helsinki, and Common Rule each envisioned a specific, discrete research project, not a tool for use on unforeseen and unforeseeable future projects.”).

114 See id. at 357.

115 See Wee, supra note 1.

116 See Hudson, Kathy L. et al., Keeping Pace with the Times – The Genetic Information Nondiscrimination Act of 2008, 358 New Eng. J. Med. 2661, 2661 (2008)CrossRefGoogle ScholarPubMed.

117 Office for Civil Rights, U.S. Dep't Health & Human Servs., Summary of the HIPPA Privacy Rule 1 (2003).

118 Id.

119 See Genetic Information Privacy, Elec. Frontier Found., https://www.eff.org/issues/genetic-information-privacy [https://perma.cc/SRU5-A8BQ] (last visited Mar. 12, 2020).

120 See Samilton supra note 103.

121 Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191, 110 Stat. 1936 (1996).

122 See 45 C.F.R. § 164.514(b)(2)(i) (2002).

123 See Dankar et al., supra note 61, at 6.

124 Elec. Frontier Found., supra note 119.

125 45 C.F.R. § 160.103 (2013); see also Elec. Frontier Found., supra note 119.

126 See Davis, supra note 38.

127 Id. (explaining that “[t]here's a delicate balance between sharing sequencing data and related data, while protecting identity of participants or patients”).

128 See generally Genetic Information Nondiscrimination Act, GINAHelp (2010), http://www.ginahelp.org/GINAhelp.pdf [https://perma.cc/4HTT-9SS5]. GINA prohibits discrimination on both the front end and back end. See id. at 2, 5. On the front end, GINA prohibits health insurers from using genetic information to determine eligibility, pricing, or coverage; on the back end, GINA prohibits employers from using genetic information to make decisions about hiring, firing, pay, privilege, or treatment. See id. Although GINA acts as floor for the regulation of genetic discrimination, some states have passed broader legislation extending discrimination protection to housing, provision of emergency services, education, mortgage lending and elections. See id. at 7.

129 Office for Human Research Prots., U.S. Dep't Health & Human Servs., Genetic Information Nondiscrimination Act Guidance (2009), https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-genetic-information-nondiscrimination-act/index.html [https://perma.cc/7AL7-4BWJ].

130 45 C.F.R. § 46.116(a)(2), (5) (2011).

131 Alaska Stat. § 18.13.010(a)(2) (2016); Colo. Rev. Stat. § 10-3-1104.7(12)-(13) (2016); Ga. Code. Ann. § 33-54-8 (2016); La. Stat. Ann. § 22:2013(E)-(F) (2017).

132 Alaska Stat. § 18.13.010(a)(1) (2016).

133 Compare Genetic Information Nondiscrimination Act of 2008 § 206, 42 U.S.C. § 2000ff-5 (2012), with Alaska Stat. § 18.13.010(a)(2), and Colo. Rev. Stat. § 10-3-1104.7(12)-(13), and Ga. Code Ann. § 33-54-8, and La. Stat. Ann. § 22:1023(E)-(F).

134 Compare 410 Ill. Comp. Stat. Ann. 513/5 (2019), with 42 U.S.C. § 2000ff-5.

135 410 Ill. Comp. Stat. Ann. 513/5(1)-(4) (2019).

136 45 C.F.R. § 160.103 (2011).

137 410 Ill. Comp. Stat. Ann. 513/31.9 (2019).

138 See Kaye, supra note 4.

139 See Food, Drug, and Cosmetic Act of 1938, Pub. L. No. 87-781, § 103, 76 Stat. 780, 783 (1962).

140 Memorandum from William H. Stewart, Surgeon General on Revised Procedure on Clinical Research and Investigation Involving Human Subjects to Head of Institutions Receiving Public Health Service Grants (July 1, 1966), https://history.nih.gov/research/downloads/Surgeongeneraldirective1966.pdf [https://perma.cc/98SE-N484]. This statement ultimately led to the development of Institutional Review Boards (“IRBs”), groups that periodically review biomedical research involving human subjects.

141 45 C.F.R. § 46.101 (2007).

142 See generally President's Comm'n, Study of Ethical Problems in Medicine and in Biomedical and Behavioral Research (1988), https://bioethics.georgetown.edu/archives/Presidents-Commission-for-Study-of-Ethical-Problems-in-Medicine-and-in-Biomedical-and-Behavioral-Research-Original-Archive-Finding-Aid.pdf [https://perma.cc/VG5R-CTPM].

143 Beskow, Laura M. et al., Informed Consent for Biobanking: Consensus-based Guidelines for Adequate Comprehension, 17 Genetics Med. 226, 226 (2015)CrossRefGoogle ScholarPubMed.

144 45 C.F.R. § 46.116 (2016).

145 Id.

146 Federal Policy for the Protection of Human Subjects, 82 Fed. Reg. 7,149, 7,168 (Jan. 19, 2017).

147 Id. at 7,247.

148 Id. at 7,216.

149 See Caulfield & Murdoch, supra note 111.

150 See McGuire & Beskow, supra note 5.

151 See id.

152 See id.

153 See Beskow et al., supra note 143, at 5.

154 The Final Rule went into effect January 19, 2018. Federal Policy for the Protection of Human Subjects, 82 Fed. Reg. 7,149, 7,149 (Jan. 19, 2017). See generally Attachment C - Updated FAQs on Informed Consent for Use of Biospecimens and Data, U.S. Dep't Health & Human Servs. (Apr. 13, 2018), https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-c-faqs-recommendations-and-glossary-informed-consent-and-research-use-of-biospecimens-and-associated-data/index.html [https://perma.cc/LT7W-U74V] (explaining the Final Rule's effect).

155 45 C.F.R. § 46.116(a) (2016).

156 45 C.F.R. § 46.116(d)(1)-(5).

157 The Revised Common Rule and Informed Consent: Broad Consent, Brany (Jan. 11, 2019), https://www.brany.com/the-revised-common-rule-and-informed-consent-broad-consent/ [https://perma.cc/3WQC-UHN3].

158 See Caulfield & Murdoch, supra note 111.

159 See, e.g., Int'l Cancer Genome Consortium, https://icgc.org/ [https://perma.cc/PWS9-7ERP] (last visited Mar. 23, 2020).

160 “The aim of these platforms is to maximize the public benefits that can be realized from data sharing, and new methodologies and approaches have had to be developed to handle the vast amounts of data created…Such pooling of data ensures that the validity of results can be confirmed in replication studies before they are relied upon, providing a further reason for sharing data.” Kaye, supra note 4, at 418 (citations omitted).

161 Id at 421.

162 Id. at 424.

163 Id. at 425.

164 Id. at 421.

165 “Certainly, the complexity of research will only continue to grow as data mining techniques replace hypothesis testing, cloud computing replaces local storage, and contracts replace legislative protections and regulators.” Thorogood, A. & Zawati, M., International Guidelines for Privacy in Genomic Biobanking (or the Unexpected Virtue of Pluralism), 43 J.L. Med. & Ethics 690, 699 (2015)Google Scholar.

166 Park, Hyun Sang et al., Development of an Integrated Biospecimen Database among the Regional Biobanks in Korea, 22 Healthcare Informatics Res. 129, 141 (2016)CrossRefGoogle ScholarPubMed; see also Kaleigh Rogers, What Can a Hacker Do with Your Genetic Information?, Vice (July 26, 2016, 2:00 PM), https://motherboard.vice.com/en_us/article/gv5w7j/what-can-a-hacker-do-with-your-genetic-information [https://perma.cc/N8CT-L3P8].

167 Collins, Francis S. & Varmus, Harold, A New Initiative on Precision Medicine, 372 New Eng. J. Med. 793, 795 (2015)CrossRefGoogle ScholarPubMed.

168 See What is the Human Genome Project?, supra note 18 (“The international, collaborative research program…has given the world a resource of detailed information about the structure, organization and function of the complete set of human genes.”).

169 Caulfield & Murdoch, supra note 111, at 4.

170 Mary A. Majumder et al., Beyond Our Borders? Public Resistance to Global Genomic Data Sharing, PLOS Biology, Nov. 2, 2016, at 1, 3-5.

171 See Caulfield & Murdoch, supra note 111, at 2.

172 See id. at 5.

173 NordForsk, Joint Nordic Registers and Biobanks: A Goldmine for Health and Welfare Research 13 (2014).

174 Joint Nordic Biobank Research Infrastructure, NordForsk, https://www.nordforsk.org/en/programmes-and-projects/projects/joint-nordic-biobank-research-infrastructure [https://perma.cc/UE7U-XTQE] (last visited Mar. 23, 2020).

175 Strategy 2019-2022, NordForsk, https://www.nordforsk.org/en/about-nordforsk/purpose-and-priorities/strategy-2019-2022 [https://perma.cc/F9XL-SLQB] (last visited Mar. 23, 2020).

176 See id.

177 NordForsk, Legislation on Biotechnology in the Nordic Countries: An Overview 2018 5 (2018) [hereinafter Legislation on Biotech in Nordic Countries].

178 Id. at 31.

179 Id.

180 Id.

181 Id.

182 Biobank Act (Act No. 688/2012) (2012) (Fin.).

183 Shakera Halim, Biobanking in Finland: A Success Story, Health Europa (Nov. 8, 2018), https://www.healtheuropa.eu/biobanking/88879/ [https://perma.cc/K5L4-W2LE]. Because the biobanking industry in Finland is a public-private partnership, Finland is currently in the process of amending the Biobanking Act to accommodate the GDPR. See id.

184 Legislation on Biotech in Nordic Countries, supra note 177, at 31.

185 See id. “There has to be an ethical evaluation of that transfer, and it has to be publicly announced in newspapers and paid advertisements and so on[.]” Halim, supra note 183.

186 See id.

187 Why in Finland?, FinnGen, https://www.finngen.fi/en/WhyinFinland [https://perma.cc/YDA6-2T2J] (last visited Mar. 24, 2019). “FinnGen brings together Finnish universities, hospitals and hospital districts, THL, Blood Service, biobanks and international pharmaceutical companies and hundreds of thousands of Finns. Because collaboration is the key to achieving breakthroughs in disease prevention, diagnosis, and treatment[.]” Id.

188 Soini, Sirpa, Biobanks as a Central Part of the Finnish Growth and Genomic Strategies: How to Balance Privacy in an Innovation Ecosystem?, 44 J.L. Med. & Ethics 24, 25 (2016)Google Scholar.

189 Human Genes Research Act (Act No. RT I 2000, 104, 685) (2000) (Est.).

190 Katharine Schwab, Estonia Wants to Collect the DNA of All Its Citizens, Atlantic (Oct. 8, 2015), https://www.theatlantic.com/health/archive/2015/10/is-a-biobank-system-the-future-of-personalized-medicine/409558/ [https://perma.cc/2HTZ-JA9E].

191 Id.

192 Id.

193 Justine Petrone, In Estonia, The Broad's Lander Sees Country as Potential Model for Implementing Genomic Medicine, GenomeWeb (Dec. 15, 2014), https://www.genomeweb.com/genetic-research/estonia-broads-lander-sees-country-potential-model-implementing-genomic-medicine#.XNsH5NNKgWo [https://perma.cc/N2CZ-HELH].

194 See FinnGen, supra note 187.

195 See Schwab, supra note 190.

196 See Legislation on Biotech in Nordic Countries, supra note 177.

197 See FinnGen, supra note 187.

198 Beskow et al., supra note 143, at 226.

199 White House, Precision Medicine Initiative: Privacy and Trust Principles 1, 2 (2015), https://obamawhitehouse.archives.gov/sites/default/files/microsites/finalpmiprivacyandtrustprinciples.pdf [https://perma.cc/89PK-ZMLS].

200 Id. at 1.

201 Id.

202 See supra Section III.B.

203 Steinsbekk, Kristin Solum et al., Broad Consent Versus Dynamic Consent in Biobank Research: Is Passive Participation an Ethical Problem?, 21 Eur. J. Hum. Genetics 897, 898 (2013)CrossRefGoogle ScholarPubMed.

204 Id.

205 See Dankar et al., supra note 61, at 9.

206 Id. iDASH stands for integrating data for analysis, anonymization, and sharing. For more information on iDASH, see Ohno-Machado, Lucia et al., iDASH: Integrating Data for Analysis, Anonymization, and Sharing, 19 J. Am. Med. Info. Ass'n 196, 196 (2011)CrossRefGoogle ScholarPubMed.

207 See Xiaoqian Jiang et al., iDASH Genome Privacy and Security Workshop, Grantome, https://grantome.com/grant/NIH/R13-HG009072-03 [https://perma.cc/R3AL-5FY2] (last visited Mar. 25, 2020). iDASH hosted a “a series workshops and competitions to call for practical and rigorous solutions to address emerging genomic privacy challenges in biomedical data analysis.” Id.

208 Thorogood & Zawati, supra note 165.

209 Joint Nordic Biobank Research Infrastructure, Nordforsk, supra note 174.

210 All of Us Research Program, Nat'l Inst. Health, https://allofus.nih.gov/ [https://perma.cc/9UXS-N6FG] (last visited Mar. 25, 2020). The All of Us Research Program was formerly named the Precision Medicine Initiative Cohort. Id.

211 See, e.g., Kristin V. Brown, Hack of DNA Website Exposes Data From 92 Million Accounts, Bloomberg (June 5, 2018, 6:11 PM), https://www.bloomberg.com/news/articles/2018-06-05/hack-of-dna-website-exposes-data-from-92-million-user-accounts [https://perma.cc/F3MA-QLNZ] (“Consumer genealogy website MyHeritage said that email addresses and password information linked to more than 92 million user accounts have been compromised in an apparent hacking incident.”).

212 See Partners HealthCare Sys., Research Consent Form: Tissue Biobank 4 (2010), https://biobank.partners.org/form/consent-form-en.pdf [https://perma.cc/V9M6-H5XZ] (Partners HealthCare System at Massachusetts General Hospital uses a consent form for biobank research that broadly informs participants, but also allows them to withdraw their data and receive pertinent secondary findings.).